NCT04381780

Brief Summary

Treatment of Fibromyalgia and CFS with Recovery Factors

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

October 11, 2021

Status Verified

October 1, 2020

Enrollment Period

7 months

First QC Date

May 6, 2020

Last Update Submit

October 3, 2021

Conditions

FibromyalgiaChronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

  • Composite VAS

    Composite of VAS for Fatigue, sleep, cognition, pain and overall well being

    6 weeks

Secondary Outcomes (1)

  • FIQ-R

    1 month

Study Arms (1)

Assessing clinical outcomes

EXPERIMENTAL

Nutritional support with Recovery Factors

Dietary Supplement: Recovery Factors

Interventions

Recovery FactorsDIETARY_SUPPLEMENT

A unique porcine serum based polypeptide nutritional support

Assessing clinical outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the ACR 2010 Amended Fibromyalgia Diagnostic Criteria or CFS CDC criteria; Score 5 or less on Energy VAS

You may not qualify if:

  • Under 18 Pregnant Other severe complicating conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacob Teitelbaum MD

Kailua, Hawaii, 96740, United States

Location

MeSH Terms

Conditions

FibromyalgiaFatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesEncephalomyelitisNeuroinflammatory DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 11, 2020

Study Start

May 6, 2020

Primary Completion

December 1, 2020

Study Completion

January 15, 2021

Last Updated

October 11, 2021

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)